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FDA Bans Generic Oxycontin in Bid to Stop Abuse

U.S. health regulators have banned all generic versions of pain drug OxyContin, fearing they will be abused.The decision comes as the U.S. Food and Drug Administration decided the therapeutics benefits of the original OxyContin no longer outweigh the risks due to the increased potential for it to be crushed up and snorted or injected to get high."The FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness," the FDA said in a statement. "Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin."Three years ago the health agency approved of a reformulated version of OxyContin that increases the risk of those adverse events. On Tuesday, it gave the nod to new abuse-deterrent labeling for the reformulated pain reliever.The FDA approved of the original formulation in Dec. 1995 b...

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  1. U.S. finds no wrongdoing in Yasmin patent settlement

    U.S. antitrust regulators found no wrongdoing in a deal made four years ago between German drugmaker Bayer AG and a division of Teva Pharmaceuticals to end patent li...

  2. Roche to Showcase Personalized Medicine, Mid-Stage Pipeline

    Roche Holding AG (ROG.VX) will tell investors attending a research-and-development presentation in London next week how it expects to grow by making increased use of...

  3. Lupin Launches Copy Of Geodon Schizophrenia Drug In US

    Lupin Ltd. (500257.BY) said Monday a unit has launched ziprasidone hydrochloride, a generic version of Pfizer Inc.'s (PFE) Geodon capsules for treating schizophrenia...

  4. FDA Cautions Statin Users on Side Effects

    U.S. health regulators are adding warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to say they may raise levels of blood sugar and ...

  5. Lupin Settles Patent Dispute Over Glumetza Diabetes Treatment

    Indian generic drug maker Lupin Ltd. (500257.BY) Thursday said it has settled a patent infringement litigation with Santarus Inc. (SNTS) and DepoMed Inc. (DEPO) over...

  6. Benefit Manager's Lipitor Move Highlights Pressure On Pfizer

    Pharmacy-benefit manager Express Scripts Inc. (ESRX) will soon make an adjustment that raises out-of-pocket costs for some customers filling prescriptions of Pfizer ...

  7. Diabetes 'Massive Challenge" as Cases Hit 366 Million

    The number of people living with diabetes has soared to 366 million, and the disease kills one person every seven seconds, posing a "massive challenge" to healthcare...

  8. Branded Drug Prices Soar as Generic Pressure Rises

    U.S. prices for brand-name drugs are rising faster than ever as patents expire on top-selling medicines and the pharmaceutical industry nervously eyes the future of ...

  9. Bayer Pharma Teams Up With Cadila To Gain Footing In India

    MUMBAI -(Dow Jones)- Moving to fill a yawning gap in its emerging market strategy, German conglomerate Bayer AG (BAYN.XE) Friday said it formed a joint venture with ...

  10. Glenmark: Unit Gets FDA OK To Sell Generic Malaria Drug

    BANGALORE -(Dow Jones)- Glenmark Pharmaceuticals Ltd. (532296.BY) Wednesday said its generic drugs unit has received final approval from the U.S. Food and Drug Admin...

  11. Lupin: Unit Gets FDA OK To Sell Generic Osteoarthritis Drug

    BANGALORE -(Dow Jones)- Lupin Ltd. (500257.BY) Friday said its U.S unit has received final approval from the U.S. Food and Drug Administration to sell its generic ve...

  12. CPPIB buys Canada toll road stake from Ferrovial

    (Recasts with analyst comment)By Sarah Morris and Cameron FrenchMADRID/TORONTO (Reuters) - Canada's biggest pension manager is spending nearly $900 million to raise ...

  1. Sanofi: U.S. Probes Disclosures to FDA About Patient Response to Plavix

    The U.S. Justice Department is investigating disclosures to the Food and Drug Administration about the variability in patient responses to the blood-thinning drug Pl...

  2. Pfizer Plans More Alliances in China

    New York-based Pfizer Inc., the world's largest drug company, plans to forge more alliances in China as pharmaceutical companies combat shrinking margins in one of t...

  3. Ranbaxy Resumes Generic Lipitor Production for U.S.

    Ranbaxy Laboratories Ltd. (500359.BY) said Friday it has resumed manufacturing generic copies of the cholesterol-lowering drug Lipitor for the U.S. market, following...

  4. Bristol-Myers to Sell Brands in Brazil, Mexico

    Bristol-Myers Squibb Co. (BMY) is seeking a buyer for a collection of brands in Mexico and Brazil that could fetch as much as $750 million, according to people famil...

  5. Why One Drug Costs $295K a Year

    There is now an approved prescription drug that costs $295,000 a year.Let's digest this for a moment. A prescription drug that costs twice as much as a college educa...

  6. FDA Requires Lower Doses for Certain Insomnia Drugs

    The Food and Drug Administration is requiring the makers of certain sleep-inducing drugs, including Ambien, to lower doses of the medicines because they have been sh...

  7. Report: Brand-Name Drug Prices Rise, But Generics Get Cheaper

    Prices for more popular brand-name prescription drugs have surged over the last year, although falling prices for generics have restrained overall U.S. spending on m...

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